CEREPAK FREEFORM XCR120510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704083696), received between Jan 2, 2024 and Jun 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 2, 2025Class IOpen, Classified

   Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

   Z-0434-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A SUBARACHNOID HEMORRHAGE (SAH) CASE WHERE THE 40-YEAR-OLD FEMALE PATIENT WHO WAS SUFFERING FROM A MYCOTIC LEFT SUPERIOR CEREBELLAR ARTERY (SCA) ANEURYSM UNDERWENT ENDOVASCULAR EMBOLIZATION PROCEDURE USING CEREPAK COILS. RIGHT FEMORAL ACCESS WAS MADE AND A 6FR. SHORT SHEATH, BENCHMARK¿ GUIDE CATHETER (PENUMBRA), 5 FR. VERT CATHETER (MERIT MEDICAL) WAS INTRODUCED TO THE RIGHT VERTEBRAL ARTERY (RVA) WITH THE BENCHMARK IN THE RVA. THE 5 FR. VERT CATHETER WAS REMOVED. THE SL-10® 45° MICROCATHETER (STRYKER) AND SYNCHRO SOFT GUIDEWIRE (STRYKER) WERE ADVANCED TO THE LEFT SUPERIOR CEREBELLA ARTERY WHERE THE PHYSICIAN HAD TROUGH ACCESSING AND AS A RESULT, CHANGED THE SYNCHRO SOFT GUIDEWIRE TO THE ARISTOTLE® 14 GUIDEWIRE (SCIENTIA VASCULAR). THEN THE COMPLAINT COIL, A 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510 / 31154786) WAS ADVANCED. THE MICROCATHETER LOST ACCESS AND THE COIL WAS REMOVED TO RESHEATH, AND DURING THE RESHEATHING, IT KINKED TWICE. THE COIL WAS NOT USED. THE ANEURYSM WAS RE-ACCESSED AND FIVE (5) CEREPAK XSFT FREEFORM WERE SUCCESSFULLY USED. ON 23-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION CLARIFIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323345 ↗
• MalfunctionJun 11, 2025Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025 TO TREAT A FISTULA, THE WIRE ON THE 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510 / 31146337) SNAPPED WHILE THE DEVICE WAS BEING FED INTO THE MICROCATHETER. NO FRAGMENT WAS GENERATED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. ON 11-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE FISTULA TARGET BY THE PROCEDURE WAS A CAVERNOUS FISTULA. THE INFORMATION INDICATED THAT THERE WAS ¿NO ATTEMPT MADE TO DETACH [THE COIL]. WHEN FEEDING COIL INTO THE MICROCATHETER, THE TECH STATED HE BROKE THE WIRE AT THE MANUAL BREAK SITE.¿ THE MICROCATHETER USED WAS A HEADWAY® DUO MICROCATHETER (TERUMO NEURO). THE COIL WAS REPLACED WITH ANOTHER 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185990 ↗
• MalfunctionJan 2, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN WAS EMBOLIZING A CAROTID-CAVERNOUS FISTULA (CCF) WITH MODERATE TORTUOSITY. THE PHYSICIAN DEPLOYED A TOTAL OF 12 COILS AD THEN USED ONYX¿ 34 LIQUID EMBOLIC AND ONYX¿ 18 LIQUID EMBOLIC (MEDTRONIC). THE FOLLOWING THREE COILS: 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510 / 31146337), 5MM X 15CM CEREPAK FREEFORM XSFT (XCR120515 / 31173107), AND 4MM X 12CM CEREPAK FREEFORM (SCR120412 / 31140706) DID NOT DETACH UTILIZING THE MANUAL DETACHMENT. IT WAS REPORTED THAT BREAKING OF THE MANUAL BREAK WAS DIFFICULT, BUT ULTIMATELY IT WAS ABLE TO EXPOSE THE PULL WIRE AND PULL BACK THE WIRE TO ATTEMPT TO DETACH THE COIL. THE DIFFICULTY WITH THE BREAKING OF THE MANUAL BREAK AT THE SORTING HAPPENED ON ALL COILS DOCUMENTED IN THIS COMPLAINT. ALL THREE COILS WERE ABLE TO BE REMOVED WITHOUT ANY NEGATIVE PATIENT IMPACT. ONE OF THE COILS REPORTEDLY DETACHED ON THE TABLE AFTER REMOVAL. THE REPORTED ISSUE RESULTED IN MINIMAL DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432760 ↗